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基于HPLC-MS/MS建立赖氨肌醇维B_(12)口服溶液中维生素B_(12)测定的新方法

A New Method for Determination of Vitamin B_(12)in Lysine Inositol Vitamin B_(12)Oral Solution by HPLC-MS/MS
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摘要 建立HPLC-MS/MS测定赖氨肌醇维B_(12)口服溶液中维生素B_(12)含量的新方法。采用HPLC-MS/MS法,以0.1%甲酸水溶液-0.1%甲酸乙腈溶液为流动相,经Acquity UPLC BEH C_(18)(2.1 mm×100 mm,1.8μm)色谱柱梯度洗脱分离,体积流量0.3 mL/min,柱温40℃,进样量5μL,多反应监测(MRM)模式,外标标准曲线法定量。维生素B_(12)在10.2~102.4 ng/mL范围内线性良好(r=0.9993),回收率为95.3%~97.6%,RSD为0.6%~3.0%,检测限为0.8 ng/mL,定量限为2.8 ng/mL。该法简便、快速、准确、灵敏度高、抗干扰能力强,适于测定赖氨肌醇维B_(12)口服溶液中维生素B_(12)的含量。 To establish a new method for content determination of vitamin B_(12)in lysine inositol vitamin B_(12)oral solution by high performance liquid chromatography tandem mass spectrometry,HPLC-MS/MS,an ACQUITY UPLC BEH C_(18)(2.1 mm×100 mm,1.8µm)was used for gradient elution separation at 40 C,0.1%formic acid aqueous-0.1%formic acid in acetonitrile as mobile phase,the flow rate was 0.3 mL/min,and the injection volume was 5μL.Multiple reaction monitoring mode(MRM)was applied with the external standard curve method to quantify.A good linear relationship was obtained upon vitamin B_(12)within the range of 10.2~102.4 ng/mL(r=0.9993),the recovery was 95.3%~97.6%,RSD was 0.6%~3.0%.Thelimit of detection is 0.8 ng/mL,and the limit of quantification was 2.8 ng/mL.The method is simple,rapid,accurate,sensitive,and shows excellent capacity to resist disturbance,which is applicable to determine the content of vitamin B_(12)in lysine inositol vitamin B2oral solution.
作者 陈佳 钱忠义 仇雅静 柏大为 江静 CHEN Jia;QIAN Zhongyi;QIU Yajing;BAI Dawei;JIANG Jing(Taizhou Institute for Drug Control,Taizhou 225300,China)
出处 《药物生物技术》 2025年第6期787-790,共4页 Pharmaceutical Biotechnology
关键词 赖氨肌醇维B_(12)口服溶液 维生素B_(12) HPLC-MS/MS法 含量测定 建立 新方法 Lysine inositol vitamin B_(12) oral solution Vitamin B_(12) HPLC-MS/MS Content determination Establishment New method
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